ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease (ASSURE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Detlef Mathey, Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier:
NCT01583608
First received: April 17, 2012
Last updated: March 20, 2013
Last verified: March 2013

April 17, 2012
March 20, 2013
April 2012
March 2013   (final data collection date for primary outcome measure)
(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE) [ Time Frame: at 24 months ] [ Designated as safety issue: Yes ]
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death
(This study has no primary outcome, all outcomes are of equal weight) MACE [ Time Frame: At time of intervention, participants will be followed for the duration of hospital stay, an expected average of 3 days, and at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death
Complete list of historical versions of study NCT01583608 on ClinicalTrials.gov Archive Site
  • Acute procedural success [ Time Frame: At the end of hospital stay (maximum of 7 days) ] [ Designated as safety issue: Yes ]
    Achievement of final in-scaffold residual stenosis of < 50% and TIMI flow 3 of the target site. Successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without occurrence of cardiac death, target vessel MI or repeat TLR during hospital stay (maximum of 7 days). In dual target lesion setting both lesions must meet clinical procedure success criteria.
  • Acute device success [ Time Frame: At time of intervention ] [ Designated as safety issue: No ]
    Successful delivery and deployment of the first scaffold at the intended target lesion (in overlapping setting both planned scaffolds) and successful withdrawal of delivery system. Attainment of < 50 % residual stenosis and TIMI flow 3 of the target site, using the BVS without the need for other non- study stents.
  • Scaffold thrombosis [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: At time of intervention, and at 6, 12,24, 36 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: At time of intervention, and at 6, 12, 24 36 months ] [ Designated as safety issue: Yes ]
  • Ischemia driven target lesion revascularisation (TLR) [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
    Target lesion denominates scaffolded segment and 5 mm beyond.
  • Major Adverse Cardiac Event (MACE) [ Time Frame: At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 36 months ] [ Designated as safety issue: Yes ]
    Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death
  • Ischemia driven target vessel revascularisation (TVR) [ Time Frame: at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
    TVR is ischemia driven.
  • Ischemia driven target vessel failure (TVF) [ Time Frame: at 6, 12, 24, 36 month ] [ Designated as safety issue: Yes ]
  • In-lesion % diameter stenosis [ Time Frame: Prior procedure ] [ Designated as safety issue: No ]
  • In-scaffold % diameter stenosis [ Time Frame: At time of intervention and at angiographic FU if applicable ] [ Designated as safety issue: No ]
  • Minimal lumen diameter (MLD) [ Time Frame: Prior and post procedure and at FU if applicable ] [ Designated as safety issue: No ]
  • In-scaffold late lumen loss (LLL) [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • Proximal and distal late lumen loss (LLL) [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • In-lesion late lumen loss [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • Response to nitroglycerin [ Time Frame: Before scaffold implantation, during angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • In-lesion angiographic binary restenosis (≥ 50%) [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: Yes ]
  • Curvature (cm-1) [ Time Frame: Prior and post procedure and at angiographic follow-up if applicable ] [ Designated as safety issue: No ]
    treated region
  • Angulation (°) [ Time Frame: Prior and post procedure and at angiographic follow-up if applicable ] [ Designated as safety issue: No ]
    Treated region
  • Clinical success [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
    Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis
  • Coronary artery bypass grafting (CABG) [ Time Frame: at 6, 12, 24, 36 month ] [ Designated as safety issue: Yes ]
  • Acute procedural success [ Time Frame: At the end of hospital stay (maximum of 7 days) ] [ Designated as safety issue: Yes ]
    Achievement of final in-scaffold residual stenosis of < 50% and TIMI flow 3 of the target site. Successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without occurrence of cardiac death, target vessel MI or repeat TLR during hospital stay (maximum of 7 days). In dual target lesion setting both lesions must meet clinical procedure success criteria.
  • Acute device success [ Time Frame: At time of intervention ] [ Designated as safety issue: No ]
    Successful delivery and deployment of the first scaffold at the intended target lesion (in overlapping setting both planned scaffolds) and successful withdrawal of delivery system. Attainment of < 50 % residual stenosis and TIMI flow 3 of the target site, using the BVS without the need for other non- study stents.
  • Scaffold thrombosis [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: At time of intervention, and at 6, 12,24, 36 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: At time of intervention, and at 6, 12, 24 36 months ] [ Designated as safety issue: Yes ]
  • Ischemia driven target lesion revascularisation (TLR) [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
    Target lesion denominates scaffolded segment and 5 mm beyond.
  • Ischemia driven target vessel failure (TVF) [ Time Frame: at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
  • Ischemia driven target vessel revascularisation (TVR) [ Time Frame: at 6, 12, 24, 36 months ] [ Designated as safety issue: Yes ]
    TVR is ischemia driven.
  • Coronary artery bypass grafting (CABG) [ Time Frame: at 6, 12, 24, 36 month ] [ Designated as safety issue: Yes ]
  • In-lesion % diameter stenosis [ Time Frame: Prior procedure ] [ Designated as safety issue: No ]
  • In-scaffold % diameter stenosis [ Time Frame: At time of intervention and at angiographic FU if applicable ] [ Designated as safety issue: No ]
  • Minimal lumen diameter (MLD) [ Time Frame: Prior and post procedure and at FU if applicable ] [ Designated as safety issue: No ]
  • In-scaffold late lumen loss (LLL) [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • Proximal and distal late lumen loss (LLL) [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • In-lesion late lumen loss [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • Response to nitroglycerin [ Time Frame: Before scaffold implantation, during angiographic follow-up if applicable ] [ Designated as safety issue: No ]
  • In-lesion angiographic binary restenosis (≥ 50%) [ Time Frame: At angiographic follow-up if applicable ] [ Designated as safety issue: Yes ]
  • Curvature (cm-1) [ Time Frame: Prior and post procedure and at angiographic follow-up if applicable ] [ Designated as safety issue: No ]
    treated region
  • Angulation (°) [ Time Frame: Prior and post procedure and at angiographic follow-up if applicable ] [ Designated as safety issue: No ]
    Treated region
  • Clinical success [ Time Frame: At time of intervention, and at 6, 12, 24, 36 months ] [ Designated as safety issue: No ]
    Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis
Not Provided
Not Provided
 
ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease
ABSORB: Initial Clinical Experience With the Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) System in the Treatment of de Novo Native Coronary Artery Lesions - a Surveillance Registry

The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery lesions in all-day clinical practice.

Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a result of everolimus release, neointimal growth is inhibited similar to DES. Finally the implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and angulation as well as response to nitroglycerine and endothelial function.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with cardiovascular disease

  • Cardiovascular Diseases
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Coronary Restenosis
  • Heart Diseases
  • Coronary Stenosis
  • Arteriosclerosis
  • Arterial Occlusive Diseases
  • Vascular Diseases
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
180
March 2016
March 2013   (final data collection date for primary outcome measure)

The recommendation to implant BVS in an individual patient is purely based on clinical grounds. These are determined by the instructions for use (IFU) of the BVS and by the clinical experience accumulated so far from clinical studies.These studies suggest that the BVS should be implanted under certain conditions, which are determined by the patient and the coronary lesion treated:

Eligible:

Regarding to patient

  • Patient ≥ 18 and ≤ 75 years with a live expectancy of at least 5 years with ischemic heart disease (chronic, NSTEMI and unstable angina) due to one or more de novo native coronary artery lesions
  • Patients with evidence of myocardial ischemia

Regarding to lesion

  • Reference vessel diameter ≥ 2.0 mm and ≤ 3.8 mm, visually estimated and by online QCA
  • Percent diameter stenosis ≥ 50% and < 100%, visually estimated and by online QCA
  • TIMI ≥1
  • Previous interventions of target vessel lesions should have been done ≥ 6 months prior to index procedure and > 10 mm distal to the target lesion
  • Previous interventions of non-target vessel lesions should have been done ≥ 30 days prior to index procedure
  • In case of >1 target lesions, those should be from different epicardial vessels

Not eligible:

Regarding to patient

  • Patient in whom antiplatelet therapy and/or anticoagulant therapy is contraindicated
  • Patient with a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, prasugrel and ticagrelor, everolimus, poly (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be adequately premedicated
  • Patient has a known diagnosis of acute myocardial infarction (STEMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
  • Patient is currently experiencing clinical symptoms consistent with STEMI
  • Patient has current unstable arrhythmias
  • Patient has a known left ventricular ejection fraction < 30%
  • Patient has received a heart transplant or any other organ transplant or is waiting for any organ transplant
  • Patient receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after procedure
  • Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease
  • Patient is receiving or scheduled to receive chronic anticoagulation therapy
  • Elective surgery is planned within the first 6 month after the procedure that will require discontinuing either aspirin or clopidogrel
  • Patient has a platelet count < 100 000 cells/mm3 or > 700 000 cells/mm3, a WBC of
  • < 3000 cells/mm3, or documented or suspected liver disease
  • Patient has known renal insufficiency
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Patient has cerebrovascular accident or transient ischemic neurological attack within the past six month
  • Patient has had a significant GI or urinary bleed within the past six months
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  • Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non.compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., les than one year)
  • Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal

Regarding to lesion

  • Aorto-ostial location
  • Left main location
  • Located within 2 mm of the origin of LAD or LCX
  • Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
  • Lesion involving a bifurcation with side branch vessel ≥ 2 mm in diameter, ostial lesion > 40% stenosed by visual estimation or side branch requiring predilation
  • Total occlusion (TIMI flow 0), prior to wire passing
  • Excessive tortuosity proximal to or within the lesion (extreme angulation (≥ 90°) proximal to or within the lesion)
  • Heavy calcification
  • Restenotic from previous intervention
  • Target vessel is containing thrombus
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01583608
BVS 12
Yes
Detlef Mathey, Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Abbott Vascular
Principal Investigator: Detlef G Mathey, MD Medical Care Center Prof. Mathey, Prof. Schofer GmbH
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP